Congress Passes Voice Vote On FDA/PDUFA Bill

Meeting in a rare Sunday session November 9 to try to clear as much aspossible before the recess, the US Congress passed - on a voice vote - a compromise bill to streamline the Food and Drug Administration and reauthorize the Prescription Drug User Fee Act, which expired October 1. The bill is now with President Clinton for signature.

The House/Senate conference committee had met several times before the Sunday session, to resolve differences between the two versions. The main variance related to how medical devices would be regulated. Senator Edward Kennedy, who had been the bill's foremost critic, endorsed the final outcome; it contains his provision giving the FDA final authority to evaluate devices if they could be used in a possibly hazardous way not specified on the label.

The compromise bill gives the FDA the right to request data for use of a device not listed on its label; this was not in the original. It also expands an existing FDA pilot program allowing independent outside reviewers to evaluate certain devices, but limits the type of devices eligible for outside review to the least risk.